2018 Recalls
7,928 federal recalls indexed for 2018 · Page 105 of 159
2018 Recall Year Insight
Federal agencies issued 7,928 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.59% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 21.7 recalls per day across the FDA, CPSC, USDA FSIS, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 159 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2018.
On this page of 50 records, severity classification shows 0 critical, 48 moderate, and 2 lower-severity recalls. The page references 20 distinct recalling firms operating in 1 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Devices (50), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.
Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2018 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.
StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608
Cook Inc.
SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for
Cardinal Health 200, LLC
SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
Roche Diagnostics Corporation
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
Siemens Healthcare Diagnostics, Inc.
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Cook Inc.
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
Cook Inc.
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
Roche Diagnostics Corporation
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Siemens Healthcare Diagnostics, Inc.
Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.
IntroMedic Co., Ltd.
Beijing Syntech Laser UL C02 Laser surgical lasers
Beijing Syntech Laser Co., Ltd
SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
Beaver-Visitec International Inc.
SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Siemens Healthcare Diagnostics, Inc.
MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Philips Medical Systems Nederlands
Beijing Syntech Laser Diode Laser surgical lasers
Beijing Syntech Laser Co., Ltd
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Siemens Medical Solutions USA, Inc.
Beijing Syntech Laser UL Station surgical lasers
Beijing Syntech Laser Co., Ltd
MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Philips Medical Systems Nederlands
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
PerkinElmer Life and Analytical Sciences, Wallac, OY
6381 M-1 Cot Fastener, catalog no. 6381000000
Stryker Medical Division of Stryker Corporation
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Siemens Healthcare Diagnostics, Inc.
Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
Beijing Syntech Laser Co., Ltd
Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Zimmer Biomet, Inc.
Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net. Wt. 4 fl. oz./118mL, Catalog No. NSP-04 The product is a topical spray used to treat discomfort and other pathological conditions affecting exposed soft tissues of the body caused by microbial infections.
Conseal International, Inc.
SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Hitachi Ltd., Medical System Operations Group
SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Philips Medical Systems Nederlands
Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Philips Medical Systems Nederlands
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Becton Dickinson & Co.
HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008
Southwest Technologies Inc
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
Cook Inc.
Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
Beijing Syntech Laser Co., Ltd
Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Zimmer Biomet, Inc.
SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Philips Medical Systems Nederlands
Alere iScreen Dx Urine Drug Screen Card
Ameditech Inc
StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013
Cook Inc.
HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i) Elasto-Gel(TM), TM7012
Southwest Technologies Inc
SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky
CooperSurgical, Inc.
SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Siemens Medical Solutions USA, Inc
PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
Polymer Technology Systems, Inc.
6376 M-1 Cot Fastener, catalog no. 6376000000
Stryker Medical Division of Stryker Corporation
Nearby Recall Years
Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.
Data Sources
- Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
- Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
- Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2018
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2018 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.